Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Agenda

Module 1: What is a clinical evaluation?

• Explanation of the terminology used in clinical evaluations

• Overview of a clinical evaluation

• The importance of clinical evidence in medical device development

Module 2: Why is it necessary to conduct a clinical evaluation?

• Where does clinical evaluation sit within the medical device process?

• Why is clinical evidence important?

• Who are the stakeholders in the process?

Module 3: What is involved in the clinical evaluation process?

• Overview of each step

• Use of equivalent products

Module 4 : What regulations govern clinical evaluations and what guidance documents should clinical evaluations be conducted to?

• An in-depth review of the available regulatory and guidance documents which can be utilised during the process and how to interpret these

Module 5: Documentation necessary for conducting a clinical evaluation

• The clinical evaluation plan

Module 6 : The literature review process

• Selecting databases and conducting searches

• How to source data and review it

• How to clarify the question on which you need to find literature

Module 7: The CER

• What is it and what is included?

• Who should write it?

• How to write it

Module 8: What is state of the art and how to conduct a risk benefit assessment of the data?

• Performance and safety analysis

Learning Objectives                                                                                                              
This one-day introductory course will cover all aspects of clinical evaluation in line with the European Medical Device Regulation (MDR) and applicable guidance documents. The programme will provide you with the tools and skills you will need to produce a high-quality clinical evaluation report (CER) for all your medical devices. You will understand the detail of what clinical data is needed, how to collect it, analyse it and produce a CER that is acceptable to the regulatory authorities and Notified Bodies. You will learn how the process fits into the development of a medical device and also the post-market aspects of clinical evidence.